Full Press Release Details
Announces Results from Two Phase 3 Clinical Trials of Serlopitant for the Treatment of Pruritus Associated with Prurigo Nodularis
BRIDGEWATER, New Jersey, April 06, 2020 -- Menlo Therapeutics
Inc. (Nasdaq: MNLO) ("Menlo" or the "Company"), a
biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology,
today announced top line results from two Phase 3 clinical trials evaluating the safety and efficacy of once daily oral serlopitant
for the treatment of pruritus (itch) associated with prurigo nodularis (PN), studies MTI-105 and MTI-106. Study MTI-105 enrolled
285 patients in the US and study MTI-106 enrolled a total of 295 patients from Germany, Poland and Austria. Patients were randomized
1:1 to either serlopitant 5mg or placebo treatment.
Study MTI-105 and Study MTI-106 did not meet their respective
primary endpoint of demonstrating statistically significant reduction in pruritus in patients
treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. In study MTI-105, 26.45% of patients
in the serlopitant group achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 10
compared to baseline (primary efficacy endpoint) vs. 20.31% of patients treated with placebo (p=0.229). In study MTI-106, 25.90%
of patients in the serlopitant group achieved a 4-point or greater improvement on the WI-NRS at week 10 compared to baseline (primary
efficacy endpoint) vs. 18.95% of patients treated with placebo (p=0.158). Results for all supportive sensitivity analyses for the
primary endpoint were comparable to the primary analyses for both studies.
"Menlo undertook a robust Phase 3 program to investigate
serlopitant as a potential treatment for pruritis associated with PN. While the data showed a numerical advantage for serlopitant
compared with placebo on the primary endpoint, the difference was not statistically significant," said David Domzalski, Chief
Executive Officer of Menlo Therapeutics Inc. "We will thoroughly analyze these data to better understand the outcome but,
at this point, we do not intend to further pursue serlopitant. I would like to thank the patients and their families, as well as
physicians and other healthcare professionals, who participated in these studies."
"Despite this news, we remain focused on building a successful
franchise in dermatology and leveraging our infrastructure to expand our pipeline," added Mr. Domzalski. "We launched
AMZEEQ as a treatment for moderate-to-severe acne at the beginning of the year and are very encouraged by positive reception so
far from both physicians and patients. FMX103, which is our 1.5% minocycline foam for the treatment of papulopustular rosacea,
is currently under review at the FDA and has been assigned a target PDUFA action date of June 2, 2020. If approved, this product
will be our second commercial launch in 2020. Additionally, our Phase 2 study for FCD 105, our combination product containing minocycline
plus the retinoid adapalene remains on track for the data readout later this quarter."
On March 9, 2020, Menlo completed its merger transaction
with Foamix Pharmaceuticals Ltd. ("Foamix") pursuant to which Foamix became a wholly-owned subsidiary of Menlo.
In the merger, Foamix shareholders received 0.5924 shares of Menlo common stock for each share of Foamix held at the closing,
plus a contingent stock right (CSR) that would convert into additional shares of Menlo common stock if both results of the
Phase 3 trials of serlopitant for pruritus associated with PN were not positive. In the case of mixed results where one trial
was positive but the other trial was not, each CSR would convert into an additional 0.6815 shares of Menlo stock, such that
the legacy Foamix shareholders would own approximately 76% of Menlo's outstanding stock as of the closing. If both
Phase 3 clinical trials were not positive, each CSR would convert into an additional 1.2082 shares of Menlo, such that the
legacy Foamix shareholders would own approximately 82% of the outstanding Menlo shares as of the closing. If both results of
the Phase 3 trials were positive, each CSR would automatically be terminated, and its holder would not be entitled to any
additional shares of Menlo. The CSRs were not transferable and are payable only to the holders of Foamix shares at the
closing of the merger.
If you were a shareholder of Foamix at the time of the closing,
you will automatically receive for each Foamix share you held at the closing, an additional 1.2082 shares of Menlo common stock
through your bank or broker plus cash in lieu of fractional shares and there is no need to take any further action. If you did
not hold Foamix shares at the closing, you will not receive the additional merger consideration.
CSR and Exchange Agent
Shareholders with questions about their shares can contact our CSR and Exchange Agent, American Stock Transfer & Trust
Company, LLC at (877) 248-6417.
About Studies MTI-105 and MTI-106
Studies MTI-105 and MTI-106 were identical Phase 3 multicenter,
placebo controlled double blind clinical trials that enrolled patients with PN who experienced pruritus for at least six
months prior to enrollment where the underlying cause for the pruritus was directly associated with PN. All patients reported a
WI-NRS score of 7 or higher at screening and a minimum weekly average WI-NRS of 6.5 for each of two weeks prior to randomization.
These trials compared treatment with serlopitant 5 mg orally once daily versus placebo for 10 weeks, with an additional post-treatment
safety assessment period. For more information, refer to ClinicalTrials.gov Identifiers: NCT03546816 and NCT03677401.
Conference call details
There will be a conference call and webcast, at 8:30 a.m.
Eastern Time today April 6th to discuss the top line Phase 3 results and provide a corporate update.
| Toll free: | 877-407-0784 |
| International: | 201-689-8560 |
| Conference ID: | 13701710 |
AMZEEQ is a topical form of the antibiotic
minocycline for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne
in adults and children 9 years of age and older. AMZEEQ is available by prescription only.
AMZEEQ should not be used for the treatment
of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age. AMZEEQ is for use on skin only
(topical use). AMZEEQ is not for use in the mouth, eyes or vagina.
Important Safety Information
| AMZEEQ should not be used in people who are allergic to AMZEEQ or any tetracycline medicine. Use of AMZEEQ should be stopped right away if a rash or other allergic symptom occurs. | |
| AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using AMZEEQ, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones. | |
| AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ. | |
| People should protect their skin from the sun while using AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of AMZEEQ should be stopped if skin is sunburned. | |
| When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms. |
AMZEEQ is a topical foam that contains minocycline, a tetracycline
medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious
side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes;
bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent
vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or
gums. People should call their doctor right away if these side effects occur.
The most common side effect of AMZEEQ is headache.
These are not all of the possible side effects with AMZEEQ.
People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical
conditions and medicines they take before using AMZEEQ.
People are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information.
About Menlo Therapeutics
Menlo Therapeutics Inc. recently
combined with Foamix Pharmaceuticals Ltd. ("Foamix") to form a different type of biopharmaceutical company
working to solve some of today's most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned
subsidiary of Menlo.
With expertise in topical medicine
innovation as a springboard, the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule
Stabilizing Technology (MST ), and has received FDA approval for the world's first topical minocycline, AMZEEQ
(minocycline) topical foam, 4%.
For more information about Menlo or
its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure
obligations under Regulation FD. Therefore, investors should monitor Menlo's website in addition to following its press
releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
Cautionary Statement Regarding
Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and
commercialization of Menlo's products and product candidates and other statements regarding the future expectations,
plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking
statements. Any forward-looking statements are based on Menlo's current knowledge and its present beliefs and